A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

Immunotherapy Clinical Trial

Official title:

A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669638
• Other study ID #: hongyanli1
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Xuanwu Hospital, Beijing
• Contact: Hongyan Li
• Phone: 18600346925
• Email: hongyanli09[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn about in the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:

• The autoantibody profile of patients

• The adverse reactions of patients

• The changes of immune cells and cytokine in patients

Description:

The goal of this observational study is to learn about the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:

• The autoantibody profile of patients

• The adverse reactions of patients

• The changes of immune cells and cytokine in patients (e.g., T cell, B cell, IL-6, etc.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old.

2. Receiving anti-PD1 immunotherapy

Exclusion Criteria:

1. Vital signs are unstable

2. Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.

Related Conditions & MeSH terms

• ADR
• Immunotherapy

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoantibodies	Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).; Cell transfection, ELISpot and ELISA are designed to be used.	Day 1
Primary	Autoantibodies	Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).; Cell transfection, ELISpot and ELISA are designed to be used.	Week 9
Primary	Autoantibodies	Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).; Cell transfection, ELISpot and ELISA are designed to be used.	Week 21
Primary	Autoantibodies	Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).; Cell transfection, ELISpot and ELISA are designed to be used.	Week 33
Primary	Autoantibodies	Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).; Cell transfection, ELISpot and ELISA are designed to be used.	Week 45
Primary	the change of immune-related adverse events	Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.	baseline to Week 45
Secondary	the immune cell (Including T cell, B cell, etc.)	Including T cell, B cell, etc. Using flow cytometry	Day 1
Secondary	the immune cell (Including T cell, B cell, etc.)	Using flow cytometry	Week 9
Secondary	the immune cell (Including T cell, B cell, etc.)	Using flow cytometry	Week 21
Secondary	the immune cell (Including T cell, B cell, etc.)	Using flow cytometry	Week 33
Secondary	the immune cell (Including T cell, B cell, etc.)	Using flow cytometry	Week 45
Secondary	the cytokine	Including IL-6, IL-17, etc.	Day 1
Secondary	the cytokine	Including IL-6, IL-17, etc.	Week 9
Secondary	the cytokine	Including IL-6, IL-17, etc.	Week 21
Secondary	the cytokine	Including IL-6, IL-17, etc.	Week 33
Secondary	the cytokine	Including IL-6, IL-17, etc.	Week 45